Calypso-based Deep Inspiration Breath Hold (DIBH) Radiation Treatments of Lung Cancer
The purpose of this study is to test the use of Calypso beacon implants as a way to determine where the lung tumor is located during radiation treatment. The Calypso beacons are small devices that are implanted in the lungs, near the tumor. They are able to send a signal to a tracking system to show where they are, and where the tumor is, as the patient holds their breath for the radiation treatment. The investigators want to find out what effects, good and/or bad, that this has on the patient and the way they treat the cancer in your lungs.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Calypso-based Deep Inspiration Breath Hold (DIBH) Radiation Treatments of Lung Cancer|
- feasibility of Calypso transponders [ Time Frame: 2 years ] [ Designated as safety issue: No ]Feasibility is defined as completion of all treatments using the DIBH treatment plan and Calypso transponders.
- reproducibility [ Time Frame: 2 years ] [ Designated as safety issue: No ]We will compare the visual vs no visual biofeedback treatments (done for each patient) by the number of treatment interruptions.
- measure the residual intrafraction tumor motion [ Time Frame: 2 years ] [ Designated as safety issue: No ]will be measured in all 3 dimensions and the euclidean distance will be calculated, which will then be correlated with the normal tissue dosimetry by regression analysis.
|Study Start Date:||April 2014|
|Estimated Primary Completion Date:||April 2016 (Final data collection date for primary outcome measure)|
Experimental: Calypso-based Deep Inspiration Breath Hold (DIBH)
This trial will investigate the feasibility of implanted anchored Beacon ® electromagnetic lung transponders (Calypso ®) to guide and monitor deep-inspiration breathhold (DIBH) treatments in patients with inoperable thoracic malignancies.
Bronchoscopic Calypso Beacon Implantation, Simulation - Free-breathing scan - 4D CT scan,- DIBH CT scan Radiation - Treatment setup, - 2 minute Calypso signal recording, - RT treatment with DIBH with or without visual biofeedback Follow-up - 3 and 6 months after RT with diagnostic CT chest
Device: Calypso Beacon Implantation
Bronchoscopic Calypso Beacon Implantation
Please refer to this study by its ClinicalTrials.gov identifier: NCT02111681
|Contact: Andreas Rimner, MD||212-639-6025|
|Contact: Michael Lovelock, PhD||212-639-6032|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Andreas Rimner, MD 212-639-6025|
|Contact: Michael Lovelock, PhD 212-639-6032|
|Principal Investigator: Andreas Rimner, MD|
|Principal Investigator:||Andreas Rimner, MD||Memorial Sloan-Kettering Cancer Center|